Choosing the right method for the treatment of refractory chronic functional constipation in children
Design
Two arm parallel group randomised trial with postoperative care and outcome assessment
Settings and conduct
In this clinical trial, all children with chronic functional constipation in age from 4 to 14, and in the year to come Amirkola Clinic Hospital, were enrolled in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 14.4 years, failure to respond to treatment with laxatives, functional constipation, including: delays in the disposal of
meconium and weight loss and abdominal pain, nausea and vomiting can not be justified. Exclusion criteria:Anatomical causes of constipation, constipation cause Saykomotor disorders hypothyroidism), anal surgery, medications that cause constipation and urinary tract infections and urinary incontinence.
Intervention groups
Intervention group: Group A cow's milk-free diet + 0.5 g / kg / day Pidrolax laxative (Company Sepidaj Karaj) for 4 weeks and for all patients in the first group of calcium syrup at a dose of 30 mg kg Klsieram factory was Ramofam.
Control group: Group B diet containing cow's milk + 0.5 g / kg / day Pidrolax laxative (Company Sepidaj Karaj) for 4 weeks.
Main outcome variables
Frequency of bowel habit per week, Frequency of painful bowel habit per week, Reduced resistance to laxative therapy, Reducing the need for therapeutic dose of laxative
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190306042946N1
Registration date:2019-04-07, 1398/01/18
Registration timing:registered_while_recruiting
Last update:2019-04-07, 1398/01/18
Update count:0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Atena Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
mohamatena@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-02, 1397/12/11
Expected recruitment end date
2020-03-01, 1398/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of cow's milk effect on chronic persistent functional Constipation in children
Public title
Evaluation of cow's milk effect on chronic persistent functional Constipation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 14.4 years and , can not be justified.
Failure to respond to treatment with laxatives
Functional constipation
delays in the disposal of meconium
weight loss
Unexplained abdominal pain
nausea and vomiting
Exclusion criteria:
Anatomical causes of constipation
Constipation cause Saykomotor disorders hypothyroidism
Anal surgery
Medications that cause constipation
Urinary tract infections and urinary incontinence
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two groups by a simple random method.
In this research, the coin toss will be used to create a random sequence in a two-group trial.
So that one of the study groups is tail and the other group is considered as a head, and according to the sample size, the same amount of coin is tossed and the subjects are divided into two groups of random allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.291
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Frequency of bowel habit per week
Timepoint
Before intervention and four weeks after intervention
Method of measurement
Rome III standard questionnaire
Secondary outcomes
1
Description
Frequency of painful bowel habit per week
Timepoint
Before intervention and four weeks after intervention
Method of measurement
Rome III standard questionnaire
2
Description
Reduced resistance to laxative therapy
Timepoint
Before intervention and four weeks after intervention
Method of measurement
Rome III Standard questionnaire
3
Description
Reducing the need for therapeutic dose of laxative
Timepoint
Before intervention and four weeks after intervention
Method of measurement
Rome III Standard questionnaire
Intervention groups
1
Description
Intervention group: Group A cow's milk-free diet + 0.5 g / kg / day Pidrolax laxative (Company Sepidaj Karaj) for 4 weeks and for all patients in the first group of calcium syrup at a dose of 30 mg kg Klsieram factory was Ramofam.
Category
Treatment - Drugs
2
Description
Control group: Group B diet containing cow's milk + 0.5 g / kg / day Pidrolax laxative (Company Sepidaj Karaj) for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Hospital Shafizadeh Amirkola
Full name of responsible person
Dr. Sanaz Mehrabani Tabari
Street address
Children's Hospital Shafizadeh Amirkola, Babol
City
Babol
Province
Mazandaran
Postal code
4731-741151
Phone
+98 11 3235 4951
Email
amirkola_hospital1342@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4718523596
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Atena Mohammadi Borkhili
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4731-741151
Phone
+98 11323549513
Email
mohamatena@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Sanaz Mehrabani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4731-741151
Phone
+98 11323549513
Email
amirkola_hospital1342@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Sanaz Mehrabani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4731-741151
Phone
+98 323549513
Email
amirkola_hospital1342@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD